Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Sponsor

Xijing Hospital of Digestive Diseases (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04697186

Collaborator

(none)

524

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia Chronic Gastritis Gastric Cancer Helicobacter Pylori Infection	Drug: Berberine Drug: Amoxicillin Drug: Rabeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Rabeprazole Drug: Bismuth	Phase 4

Detailed Description

Detailed Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

524 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Berberine Hydrochloride, Amoxicillin and Rabeprazole Triple Therapy in the First Eradication of Helicobacter Pylori

Actual Study Start Date :

Jan 7, 2021

Anticipated Primary Completion Date :

Dec 20, 2021

Anticipated Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: berberine , amoxicillin and rabeprazole triple therapy Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.	Drug: Berberine berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID. Drug: Amoxicillin berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID. Other Names: Amoxy Drug: Rabeprazole berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID. Other Names: Pariet
Active Comparator: Bismuth-containing Quadruple Therapy amoxicillin 1000 mg，clarithromy 500mg，rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days.	Drug: Amoxicillin Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID Other Names: Amoxy Drug: Clarithromycin Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID Other Names: Krashen Drug: Rabeprazole Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID Other Names: Pariet Drug: Bismuth Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Arm

Intervention/Treatment

Experimental: berberine , amoxicillin and rabeprazole triple therapy

Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.

Drug: Berberine

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Drug: Amoxicillin

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Other Names:

Amoxy

Drug: Rabeprazole

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Other Names:

Pariet

Active Comparator: Bismuth-containing Quadruple Therapy

amoxicillin 1000 mg，clarithromy 500mg，rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Drug: Amoxicillin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Other Names:

Amoxy

Drug: Clarithromycin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Other Names:

Krashen

Drug: Rabeprazole

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Other Names:

Pariet

Drug: Bismuth

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication [28 days after treatment]
The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.

Secondary Outcome Measures

symptoms effective rate [14 days of treatment, and 28 days after treatment]
Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
adverse events [14 days of treatment, and 28 days after treatment]
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18~70,both gender.
Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
Patients are willing to receive eradication treatment.
Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.

Exclusion Criteria:

Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
Patients with contraindications or allergies to the study drug.
Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
Pregnant or lactating women.
Underwent upper gastrointestinal Surgery.
Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
Patients have symptom of dysphagia.
Evidence of bleeding or iron efficiency anemia.
A history of malignancy.
Drug or alcohol abuse history in the past 1 year.
Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
Patients who has psychological problem or poor compliance.
Enrolled in other clinical trials in the past 3 months.
Refuse to sign informed consent.